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CytoJournal 2009,  6:17

Market survey predictions on the future of US Pap testing

Department of Pathology, Magee-Women's Hospital of University of Pittsburgh Medical Center, 300 Halket Street, Pittsburgh, PA 15213, USA

Date of Submission06-Jul-2009
Date of Acceptance27-Jul-2009
Date of Web Publication18-Sep-2009

Correspondence Address:
R Marshall Austin
Department of Pathology, Magee-Women's Hospital of University of Pittsburgh Medical Center, 300 Halket Street, Pittsburgh, PA 15213
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/1742-6413.55885

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How to cite this article:
Austin R M, Benstein B, Bentz J, Bigner S, Freund GG, Rocco GL, Ramzy I, Savaloja L, Shidham VB. Market survey predictions on the future of US Pap testing. CytoJournal 2009;6:17

How to cite this URL:
Austin R M, Benstein B, Bentz J, Bigner S, Freund GG, Rocco GL, Ramzy I, Savaloja L, Shidham VB. Market survey predictions on the future of US Pap testing. CytoJournal [serial online] 2009 [cited 2019 Dec 5];6:17. Available from: http://www.cytojournal.com/text.asp?2009/6/1/17/55885

Predicting the future in almost any realm of human endeavor is a challenging and humbling undertaking, given the large number of variables often at play, uncertainty as to how known variables impact each other, the frequent presence of significant but largely unrecognized variables, and the even more daunting task of estimating timing in the unfolding of future changes. With the identification of human papilloma virus (HPV) as the dominant etiologic agent of cervical cancer, [1,2] the introduction of FDA-approved adjunctive HPV DNA testing with cytology as early forms of etiology-based screening [3,4] and the recent introduction of FDA-approved vaccination for the two leading high-carcinogenic-risk HPV types, [5] it is perhaps not surprising that recent predictions about the future structure of cervical cancer prevention efforts in the USA and the size and scope of the role of the Papanicolaou test in US cervical cancer screening have varied greatly. [6-13]

In an effort to help members assess the future of the Pap test market in the USA, the American Society of Cytopathology (ASC) recently contracted with an external research group FGI Research of Chapel Hill, North Carolina, to survey a diverse group of US Pap test providers on their personal expectations for future Pap testing volume in their practices. Questions to be asked of Pap test providers were initially developed by the ASC Long Range Planning Committee and subsequently edited by the ASC Executive Board and FGI Research. Along with the specific questions asked, the Survey findings are presented here for further consideration by the ASC membership [see PDF of FGI PowerPoint presentation- Report of findings]-[Additional file 1].

 » Commentary Top

The respondents' predictions that 5 years from now providers expect to order roughly the same number of Pap tests that they order now per 30 - day period can be interpreted in several ways. People often expect present circumstances to continue indefinitely, even as prior experience tells them that such expectations may often prove unrealistic.

Nevertheless, we believe that this major prediction of the market survey underscores the inherent conservatism and resistance to change in the current US cervical cancer prevention system, one grounded in multigenerational expectations of US women that they should present themselves for periodic (opportunistic) Pap-based wellness visits and prevention services to (predominantly private practice) primary care providers. [14,15]

Even gradual and minor changes to this opportunistic US screening system could present major challenges for overall screening compliance and effectiveness in the absence of a programmatic organized system such as the systems present in much of Europe and Australia. [16,17] Some suspect that this market-based conservatism substantially accounts for the still limited US adoption of routine Pap and HPV co-testing in women 30 and older compared to the more widespread adoption for reflex HPV testing after ASCUS Pap results. [8] The even more limited adoption of recommended extended screening intervals after "double-negative" Pap and HPV co-test results [18-20] further reflects market resistance to changes perceived as interfering with traditional annual women's wellness visits. [14] Intrinsic market conservatism is also consistent with the observation that that three-quarters of providers surveyed believe that the trends they are anticipating for the next 5 years will continue into the next 10 - 15 years.

Despite prevailing expectations by many providers that little will change, the survey does indicate that providers recognize several new factors which have already had an impact on numbers of Pap tests they have ordered in the recent past and which they also realize could further impact the number of Pap tests they will order in the future. Clinical guidelines on the recommended frequency of screening [18-20] in particular are acknowledged (blamed) by gynecologists as having negatively influenced the number of Pap tests ordered in the recent past, a trend they expect to continue. Despite the perceived influence of guidelines on Pap volume, respondents also commonly reported that they often simply elect not to follow guidelines. This tendency has been reported in a variety of clinical settings. [21-24] Adjunctive HPV DNA testing is also identified as a factor decreasing Pap testing, both with reflex HPV testing after ASCUS (presumably due to fewer repeat Paps) and with Pap and HPV co-testing in women 30 and older (increased recommended screening intervals). Insurance coverage is also acknowledged as a significant factor potentially causing fewer Pap tests. [8] Few respondents expect the HPV vaccine to eliminate the need for Pap testing in the foreseeable future, and until population-based data on the performance of cytology, HPV testing, and alternative screening or triage interventions become available, modifying current screening guidelines have been recently acknowledged as premature. [25]

One confusing finding in the survey is the expectation by 43% of respondents that they "foresee HPV DNA testing to be used for primary screening with cytology as triage."

Among the respondents reporting this expectation, most said that they expect this change in as little as 2 - 5 years. Given the potential of primary HPV testing with cytology triage (cytology only after a positive HPV test) to substantially decrease Pap testing, [26,27] this finding is inconsistent with other survey data, and therefore we believe that respondents did not accurately understand this question. Since HPV DNA testing is already used for "primary screening" in the form of FDA-approved Pap and HPV co-testing, we believe that it is likely that many respondents simply misunderstood "cytology triage" as Pap and HPV co-testing. The reported answers to the survey question are then perhaps best interpreted as reflecting expectations that the option of Pap and HPV co-testing, now reportedly selected for testing by around 25 - 30% of women 30 and older, will experience continued, gradual increased market uptake.

Many factors could significantly impact the likelihood of realizing the survey respondents' expectations for gradual and limited change in Pap testing. A severe economic downturn, for example, has already increased pressure for national healthcare reform and cost-containment measures. [28,29] These pressures could play into the hands of those calling for increased screening intervals and restricted guideline-based reimbursement. [8] On the other hand, any move in this direction is likely to be opposed by women consumers who believe that recommendations to screen later and less frequently stem from financial considerations rather than balanced safety concerns. [30] If an HPV DNA test were at some point in the next decade to become FDA approved for primary screening with cytology triage, as proposed by some in Europe, [26] more significant changes in screening practices could certainly ensue. For now, these experiments appear to more likely to unfold in national screening programs in Europe and elsewhere overseas. For the foreseeable future, cervical cancer screening will remain crucial to cervical cancer prevention. Vaccination at this point is for cervical cancer prevention in the next generation of US women. FDA-approved cytology-based screening remains in the USA the most effective prevention modality for the current generation of women.

 » Acknowledgment Top

The American Society of Cytopathology gratefully acknowledges funding for this survey by Hologic Corporation (Bedford, MA) through a grant provided to the American Society of Cytopathology Foundation. The donor was neither involved in either the creation and editing of the survey questions nor in the selection of the survey company, FGI Research of Chapel Hill, North Carolina. FGI Research has no financial relationship with the donor.

 » Competing Interest Statement by all Authors Top

No competing interest to be declared by any of the authors.

 » Authorship Statement by all Authors : Top

All authors declare that we qualify for authorship as defined by ICMJEicmje.org/#author.

 » References Top

1.Zur Hausen H. Papillomaviruses in the causation of human cancers: A brief historical account. Virology 2009;384:260-5.  Back to cited text no. 1      
2.Walboomers JM, Jacobs MV, Manos MM, Bosch FX, Kummer JA, Shah KV, et al. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol 1999;189:12-9.  Back to cited text no. 2      
3.Solomon D, Schiffman M, Tarone R; ALTS Study group. Comparison of three management strategies for patients with atypical squamous cells of undetermined significance: Baseline results from a randomized trial. J Natl Cancer Inst 2001;93:293-9.  Back to cited text no. 3      
4.Wright TC Jr, Schiffman M. Adding a test for human papillomavirus DNA to cervical-cancer screening. N Engl J Med 2003;348:489-90.  Back to cited text no. 4      
5.Garland SM, Hernandez-Avila M, Wheeler CM, Perez G, Harper DM, Leodolter S, et al. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med 2007;356:1928-43.  Back to cited text no. 5      
6.Eltoum IA, Roberson J. Impact of expected changes in national papanicolaou test volume on the cytotechnology labor market: An impending crisis. Am J Clin Pathol 2007;128:665-70.   Back to cited text no. 6      
7.Eltoum IA Roberson J. Impact of HPV testing, HPV vaccine development, and changing screening frequency on national pap test volume. Cancer Cytopathol 2007;111:34-40.   Back to cited text no. 7      
8.Solomon D, Breen N, McNeel T. Cervical cancer screening rates in the United States and the potential impact of implementation of screening guidelines. CA Cancer J Clin 2007;57:105-11.  Back to cited text no. 8      
9.Schiffman M. Integration of human papillomavirus vaccination, cytology, and human papillomavirus testing. Cancer Cytopathol 2007;11:145-53.  Back to cited text no. 9      
10.Covell J, Stoler MH. Human papillomavirus testing, vaccination, and gynecologic screening. Am J Clin Pathol 2007;128:726-8.  Back to cited text no. 10      
11.Austin RM. Dismantling of the US cytotechnology educational infrastructure is premature and carries significant risks. Arch Pathol Lab Med 2008;132:154-8.  Back to cited text no. 11      
12.Stoler MH. HPV vaccine to transform testing protocl, profession sooner rather than later. Critical Values 2009;2:26-7.  Back to cited text no. 12      
13.Austin RM. Not so fast: Pap to remain screening centerpiece for foreseeable future. Critical Values 2009;2:28-9.   Back to cited text no. 13      
14.American College of Obstetricians and Gynecologists. Routine cancer screening. ACOG Committee Opinion No. 356. Obstet Gynecol 2006;108:1611-3.  Back to cited text no. 14      
15.Sirovich BE, Welch HG. The frequency of Pap smear screening in the United States. J Gen Intern Med 2004;19:243-50.  Back to cited text no. 15      
16.Miller AB. The (in) efficiency of cervical screening in Europe. Eur J Cancer 2002;38:321-6.  Back to cited text no. 16      
17.Canfell K, Sitas F, Beral V. Cervical cancer in Australia and the United Kingdom: Comparison of screening policy and uptake, and cancer incidence and mortality. Med J Aust 2006;185:482-6.   Back to cited text no. 17      
18.Saslow D, Runowicz CD, Solomon D, Moscicki AB, Smith RA, Eyre HJ, et al. American Cancer Society guideline for the early detection of cervical neoplasia and cancer. CA Cancer J Clin 2002;52:342-62.  Back to cited text no. 18      
19.US Preventive Services Task Force. Screening for Cervical Cancer. Rockville, MD: Agency for Healthcare Research and Quality; 2003. Available from: http://www.ahrq.gov/clinic/uspstf/uspscerv.htm. [accessed on 2006 Nov 20].  Back to cited text no. 19      
20.ACOG Committee on Practice Bulletins. ACOG Practice Bulletin: Clinical management guidelines for obstetrician-gynecologists. Number 45, August 2003. Cervical cytology screening (replaces committee opinion 152, March 1995). Obstet Gynecol 2003;102:417-27.  Back to cited text no. 20      
21.Noller KL, Bettes B, Zinberg S, Schulkin J. Cervical cytology screening practices among obstetrician-gynecologists. Obstet Gynecol 2003;102:259-65.  Back to cited text no. 21      
22.Saraiya M, Roland K, Benard V, Richardson L. HPV co-testing in the United States: Minimal impact on screening intervals. J Lower Genital Tract Dis 2008;12:170-1.  Back to cited text no. 22      
23.Cooper CP, Saraiya M, McLean TA, Hannan J, Liesmann JM, Rose SW, et al. Pap test intervals used by physicians serving low-income women through the National Breast and Cervical Cancer Early Detection Program. J Women′s Health 2005;14:670-8.  Back to cited text no. 23      
24.Ubel PA, Jepson C, Baron J, Hershey JC, Asch DA. The influence of cost-effectiveness information on physicians′ cancer screening recommendations. Soc Sci Med 2003;56:1727-36.  Back to cited text no. 24      
25.Massad LS, Einstein M, Myers E, Wheeler CM, Weintzensen N, Solomom D. The impact of human papillomavirus vaccination on cervical cancer prevention efforts. Gynecol Oncol 2009;114: 360-4.   Back to cited text no. 25      
26.Cuzik J, Clavel C, Petry KU, Meijer CJ, Hoyer H, Ratnam S, et al. Overview of the European and North American studies on HPV testing in primary cervical cancer screening. Int J Cancer 2006;119:1095-101.  Back to cited text no. 26      
27.Franco EL, Cuzik J. Cervical cancer screening following prophylactic human apillomavirus vaccination. Vaccine 2008;26S:A16-23.  Back to cited text no. 27      
28.Brook RH. The Science of Healthcare Reform. JAMA 2009;301:2486-7.  Back to cited text no. 28      
29.Rittenhouse DR, Shortell SM. The patient-centered medical home: Will it stand the test of health reform? JAMA 2009;301:2038-40.  Back to cited text no. 29      
30.Sirovich BE, Woloshin S, Schwartz LM. Screening for cervical cancer: Will women accept less? Am J Med 2005;118:151-8.  Back to cited text no. 30      

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